# K240307: VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Vitavitro Biotech Co., Ltd.
- Decided: Aug 16, 2024 after 196 days
- Product code: MQF (Catheter, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K013536 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013536: Emtrac; Delphin; Semtrac 2000 Set, Gynetics Medical Products NV (2001) Summary page 5.

## Indications for use
VitaVitro Embryo Transfer Catheter is used to place in vitro fertilized (IVF) embryos into the uterine cavity

Source page: https://510kreport.com/device/K240307
Methodology: https://510kreport.com/methodology